Flexible wireless patch for physiological monitoring and methods of manufacturing the same

ABSTRACT

Provided herein is an integrated wireless patch comprising a contact layer, an electronics layer, and a battery layer. The contact layer is a substrate having gel cutouts. The electronics layer can be folded into contact with the contact layer. The battery layer can be folded into contact with the electronic layer. Further provided herein is a method of manufacturing a wireless integrated patch comprising folding a substrate comprising at least one cutout, at least one contact disk in communication with a surface of a patient through the cutout, and battery terminals, wherein the at least one cutout, the at least on contact, and the battery terminals are adaptable to be located in different layers after the substrate is folded.

CROSS-REFERENCE

This application is a Continuation Application of U.S. application Ser.No. 12/739,561, filed on Nov. 3, 2010, which is a National Stage Entryof PCT/US08/80695, filed Oct. 22, 2008, which claims the benefit of U.S.Provisional Application Nos. 60/982,402, filed Oct. 24, 2007, and60/982,233, filed Oct. 24, 2007, which applications are incorporatedherein by reference in their entirety.

This application is related to U.S. Provisional Application No.60/943,539, filed Jun. 12, 2007; and to PCT/US08/64800, filed on May 23,2008 which claimed priority to U.S. Provisional Application No.60/940,072, filed on May 24, 2007, which applications are incorporatedherein by reference in their entirety.

BACKGROUND OF THE INVENTION

Monitoring physiological conditions of the human body is an importantcomponent of health care. Although the monitoring can be performedperiodically by a health care professional, increasingly the task isbeing handled by electronics that connect the patient to a computerizedsystem for data storage, presentation and retrieval. These electronicsystems consist of sensors, signal conditioners, power sources and othercomponents needed for the specific physiological conditions beingmonitored. Most sensors used in monitoring physically contact the body,requiring a method for connecting sensors to the rest of the electronicsystem. In the past, wires were the only option for this connection, butincreasingly wireless methods are being employed. One such wirelessdesign, [P1], describes a sensor patch that attaches to the patientduring the monitoring period and sends physiological measurement data tothe rest of the system over a radio link. This sensor patch includesinterface electrodes, signal conditioning circuits, digitizingconverters, a wireless data link (radio), support circuits and a powersource (battery). Including all of these components in a patch thatmight be worn on the body for several days presents several design andmanufacturing challenges. This patent describes a method formanufacturing such a patch.

SUMMARY OF THE INVENTION

Provided herein is an integrated wireless patch which comprises acontact layer comprising a substrate, an electronic layer folded intocontact with the contact layer, and a battery layer folded into contactwith the electronic layer. The battery layer comprises battery terminaltabs. Additionally, the battery layer can further comprise at least oneantenna. The patch can be adaptable to be assembled by positioning theelectronic layer between the contact layer and the battery layer.Furthermore, the patch can comprise an adhesive layer adaptable to belocated between the contact layer and the electronic layer. In someembodiments, the patch can further comprise a battery. The contact layercan comprise at least one contact adaptable to be in communication witha surface of a patient. The contact layer can further comprise anadhesive surround positioned around the contact. Additionally, the patchcan further comprise at least one antenna. The patch can also compriseat least one application-specific integrated circuit on the electroniclayer.

Further provided herein is a method of manufacturing a wirelessintegrated patch comprising the steps of: folding a substrate comprisingat least one cutout, at least one contact disk in communication with asurface of a patient through the cutout, and battery terminals, whereinthe at least one cutout, the at least on contact, and the batteryterminals are adaptable to be located in different layers after thesubstrate is folded. Additionally, the method can comprise the step ofattaching a battery to the battery terminals. Cutouts can be created inthe substrate prior to the folding step. Furthermore, the method canfurther comprise the step fabricating at least one contact on thesubstrate prior to the folding step. In some embodiments of the method,the method can further comprise the step of attaching an ASIC to thesubstrate and further comprising the step of connecting the at least onecontact to the ASIC with a trace. An antenna can be connected to theASIC as part of the method. Additionally, an adhesive spacer can beinserted he between two layers of the folded substrate. The adhesivespacer can be inserted in between the cutout layer and the contactlayer. The method can further comprise the step of applying gel to thecutout area on the contact layer. Furthermore, an adhesive washer can beattached to the cutout on the contact layer. In some embodiments, themethod further comprises the step of cutting spiral cuts, the spiralcuts adaptable to surround the cutout. The method provided herein canfurther comprise more than one cutout on the contact layer and more thanone contact on the electronics layer corresponding to the cutouts on thecontact layer. Further provided herein is a wireless integrated patchproduced according to the above described method.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by referencein their entirety.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 illustrates an expanded view of one embodiment of an integratedpatch;

FIGS. 2A-2E illustrate one method for fabricating an integrated patch;

FIGS. 3A-3 c illustrate one method for assembling an integrated patch;and

FIG. 4 illustrates a schematic cross-sectional view of one electrode ofan integrated patch.

DETAILED DESCRIPTION OF THE INVENTION

Provided herein is an integrated wireless patch which comprises acontact layer comprising a substrate, an electronic layer folded intocontact with the contact layer, and a battery layer folded into contactwith the electronic layer. The battery layer comprises battery terminaltabs. Additionally, the battery layer can further comprise at least oneantenna. The patch can be adaptable to be assembled by positioning theelectronic layer between the contact layer and the battery layer.Furthermore, the patch can comprise an adhesive layer adaptable to belocated between the contact layer and the electronic layer. In someembodiments, the patch can further comprise a battery. The contact layercan comprise at least one contact adaptable to be in communication witha surface of a patient. The contact layer can further comprise anadhesive surround positioned around the contact. Additionally, the patchcan further comprise at least one antenna. The patch can also compriseat least one application specific integrated circuit (ASIC) on theelectronic layer.

I. Devices

FIG. 1 illustrates the components of a wireless patch. The wirelesspatch can use a multi-chip module or ASIC to integrate most of theneeded functions into a single module. The ASIC can be a single chipdevice. In some embodiments, additional components can be added to theASIC as needed. The FIG. 1 illustrates a substrate comprising a contactlayer 1A, an electronics layer 1B, and a battery layer 1C. The contactlayer 1A can come in contact with the surface of a patient. The contactlayer can have gel cutouts 9. The gel cutouts 9 can be filled with a gel11 that conducts an electrical signal from the surface of the patient.In some embodiments, the gel cutouts 9 can be surrounded by spiralcutouts 8. The spiral cutout 8 can provide flexibility between thecontact layer and the skin of the patient and can serve to reduce strainbetween the contact layer and the skin surface. In some embodiments, thecutouts 9 of the contact layer 1A can have adhesive washers 10 thatsurround the cutouts 9. An electrode gel 11 can be used in conjunctionwith the adhesive washers 10 and the cutouts 9 to facilitatecommunication between the surface of the patient and the contacts 6 onthe electronics layer 1B.

The electronics layer 1B comprises at least one contact pad 6. In someembodiments, multiple contact pads 6 can be fabricated on theelectronics layer 1B, as shown in FIG. 1. The contact pads 6 can haveconducting traces 7 that relay the signal sensed by the contact pads 6to an application specific integrated circuit (ASIC) 3 located on theelectronics layer 1B. The ASIC can be mounted directly on the substrate,with no additional support.

A battery can be used to power the patch. The battery can be incommunication with the patch through the battery layer. In someembodiments, the battery layer 1C is a truncated circle, as shown inFIG. 1. In some embodiments, the battery layer can be substantiallycircular. The battery layer 1C, as shown in FIG. 1, can have batteryterminals 5 that come in contact with a battery 2. The battery terminalscan be spot welded or conductive glued to the battery layer. A cover orinsulating film can be put over the top, with holes left for air accessin the case of the battery is a zinc-air battery. The battery 2 powersthe ASIC 3 through traces 7 between the battery terminals 5 and the ASIC3. Additional support can be provided to the battery. The battery layercan further be adaptable to be used with a flat battery such as, forexample purposes only, a watch battery, where the flat battery ismounted directly onto the battery layer.

In some embodiments, the battery layer 1C further comprises an antenna 4that is in communication with the ASIC 3. Additionally, an input/output(I/O) used to communicate information from the patch to a user can beincluded on the battery layer. Input/outputs include, but are notlimited to, light emitting diodes (LEDs), switches, or any othersuitable indicator or actuator.

Additionally shown in FIG. 1 is an adhesive spacer 12. The adhesivespacer 12 can be located between the contact layer 1A and theelectronics layer 1B, in order to prevent signal leakage betweenelectrodes. The adhesive spacer can also be used to add a bit ofthickness to keep the application specific integrated circuit projectingout too far from the electronics layer. A cutout 13 can be located onthe adhesive spacer 12 to accommodate the ASIC 3 on the electronicslayer 1B. Furthermore gel cutouts 14 of the adhesive spacer 12 cancorrespond to the gel cutouts 9 and contacts 6 of the contact layer 1Aand the electronics layer 1B, respectively.

II. Methods of Manufacturing

Further provided herein is a method of manufacturing a wirelessintegrated patch comprising the steps of: folding a substrate comprisingat least one cutout, at least one contact disk in communication with asurface of a patient through the cutout, and battery terminals, whereinthe at least one cutout, the at least on contact, and the batteryterminals are adaptable to be located in different layers after thesubstrate is folded. Additionally, the method can comprise the step ofattaching a battery to the battery terminals. Cutouts can be created inthe substrate prior to the folding step. Furthermore, the method canfurther comprise the step fabricating at least one contact on thesubstrate prior to the folding step. In some embodiments of the method,the method can further comprise the step of attaching an ASIC to thesubstrate and further comprising the step of connecting the at least onecontact to the ASIC with a trace. An antenna can be connected to theASIC as part of the method. Additionally, an adhesive spacer can beinserted he between two layers of the folded substrate. The adhesivespacer can be inserted in between the cutout layer and the contactlayer. The method can further comprise the step of applying gel to thecutout area on the contact layer. Furthermore, an adhesive washer can beattached to the cutout on the contact layer. In some embodiments, themethod further comprises the step of cutting spiral cuts, the spiralcuts adaptable to surround the cutout. The method provided herein canfurther comprise more than one cutout on the contact layer and more thanone contact on the electronics layer corresponding to the cutouts on thecontact layer. Further provided herein is a wireless integrated patchproduced according to the above described method.

Provided herein is a method of manufacturing a wireless patch withintegrated circuits and a battery. The patch can be manufactured usingmaterials that are disposable or recyclable, while still meeting thetechnical requirements of the market for example purposes only, size,weight, battery life, functionality, comfort, among others. The processfor manufacturing one embodiment of a wireless patch with integratedcircuits is described below. While the steps of manufacturing such awireless patch are outlined in one order, it should be noted that thesteps for manufacturing the device can be done in any suitable order.

FIGS. 2A-2E illustrate one method for fabricating a wireless integratepatch. FIG. 2A illustrates a patch outline that has been cut from apiece of substrate material 1. In some embodiments, the substrate 1 iscut such that three separate sections are defined creating a firstsection 1A, a middle section 1B, and an end section 1C, as shown in FIG.2A. The beginning section 1A corresponds to the contact layer, asdescribed in FIG. 1. The middle section 1B and end section 1C correspondto the electronics layer and the battery layer, respectively. In someembodiments, the substrate is cut in one continuous strip. The substrate1 can be cut so that the beginning section 1A and middle section 1B arecut in substantially the same shape, as seen in FIG. 2A. The end section1C can be cut so that is only partially the size as the beginning andmiddle sections, as shown in FIG. 2A. Alternatively, the end section 1Ccan be cut so that the end section is the substantially the same shapeas the beginning and middle sections.

After the substrate has been cut to the desired shape and/or size, atleast one cutout 9 can be formed in the beginning part 1A of thesubstrate 1. The cutout 9 can provide access between a contact disk 6and the patient's skin. In some embodiments, multiple cutouts 9 areprovided are shown in FIG. 2B. Additionally, spiral slots 8 can be cutin the substrate 1 surrounding the cutout 9. The spiral slot 8 can helpto alleviate tension between the substrate and the surface of the skin,wherein the tension is caused by slight changes in the surfacecharacteristics of the skin. The spiral slot surrounding the cutout hasbeen previously described in U.S. Ser. No. 60/982,233 filed Oct. 24,2007, entitled Multi-Electrode Sensing Patch for Long-term PhysiologicalMonitoring with Swappable Electronics, Radio and Battery (Beck).

After the cutouts 9 have been formed, at least one contact disk 9 can befabricated on the surface of the middle section 1B of the substrate. Thecontact can be fabricated from metal, polymer, or composite or anysuitable combination thereof. The contact can be fabricated by anysuitable method including, but not limited to, microfabrication,printing, chemical deposition or other techniques. Multiple contacts canbe fabricated on the substrate, as shown in FIG. 2C. Any suitable numberof contacts can be fabricated on the substrate. Traces 7 from thecontacts 6 can also be fabricated. In addition to the contacts, batterycontact points can be fabricated on the end section of the substrate.

After the contacts and traces from the contact have been fabricated, anapplication specific integrated circuit 3 can be mounted on thesubstrate 1 as shown in FIG. 2D. Additionally, an antenna 4 can bemounted on the substrate 1. Before the device is folded into its finalconfiguration a battery 2 can be attached to the substrate 1 at thebattery terminals 5. The device can be folded after the battery has beenattached. Alternatively, the device can be folded and then the batteryattached.

FIGS. 3A-3C illustrate a wireless integrated patch being assembled. FIG.3A illustrates a fabricated wireless integrated patch before beingassembled. The patch can then be assembled by folding the patch using az-fold as shown in FIG. 3B, wherein the contact layer 1A is in contactwith the electronics layer 1B, and the electronics layer 1B is incontact with the battery layer 1C. An adhesive spacer 12 can be insertedin between the contact layer 1B and the electronics layer 1C. Once thedevice is folded as shown in FIG. 3C, the adhesive washers 10 and gel 11can be applied to the contact layer 1A.

A schematic cross section of a portion of the patch is shown in FIG. 4,in particular the contact layer 1A and electronics layer 1B and relatedstructures. As shown in FIG. 4, the contact layer 1A can be stacked onthe electronics layer 1B with an adhesive spacer 12 located in betweenthe contact layer 1A and the electronics layer 1B. The contact 6 on theelectronics layer 1B is in communication with the surface of a patientthrough the gel cutout 9 on the contact layer 1A and electrode gel 11.In some embodiments, the contact layer 1A can be adhered to the skin ofa patient using adhesive washers 10 surrounding the get cutout 9 of thecontact layer 1A. Spiral cutouts 8 surrounding the gel cutout 9 can helpalleviate any tension between the patch and the skin surface.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. An integrated wireless patch which comprises: acontact layer comprising a substrate; an electronic layer folded intocontact with the contact layer; and a battery layer folded into contactwith the electronic layer.
 2. The patch of claim 1 wherein the batterylayer comprises battery terminal tabs.
 3. The patch of claim 1 whereinthe battery layer further comprises at least one antenna.
 4. The patchof claim 1 wherein the patch is adaptable to be assembled by positioningthe electronic layer between the contact layer and the battery layer. 5.The patch of claim 1 further comprising an adhesive layer adaptable tobe located between the contact layer and the electronic layer.
 6. Thepatch of claim 1 further comprising a battery.
 7. The patch of claim 1wherein the contact layer comprises at least one contact adaptable to bein communication with a surface of a patient.
 8. The patch of claim 7wherein the contact layer further comprises an adhesive surroundpositioned around the contact.
 9. The patch of claim 1 furthercomprising at least one antenna.
 10. The patch of claim 1 furthercomprising at least one application-specific integrated circuit on theelectronic layer.
 11. A method of manufacturing a wireless integratedpatch comprising: folding a substrate comprising at least one cutout, atleast one contact disk in communication with a surface of a patientthrough the cutout, and battery terminals, wherein the at least onecutout, the at least on contact, and the battery terminals are adaptableto be located in different layers after the substrate is folded.
 12. Themethod of claim 11 further comprising the step of attaching a battery tothe battery terminals.
 13. The method of claim 11 further comprising thestep of creating a cutout in the substrate prior to the folding step.14. The method of claim 11 further comprising the step fabricating atleast one contact on the substrate prior to the folding step.
 15. Themethod of claim 14 further comprising the step of attaching an ASIC tothe substrate and further comprising the step of connecting the at leastone contact to the ASIC with a trace.
 16. The method of claim 15 furthercomprising the step of connecting an antenna to the ASIC.
 17. The methodof claim 11 further comprising the step of inserting an adhesive spacerbetween two layers of the folded substrate.
 18. The method of claim 17wherein the adhesive spacer is inserted in between the cutout layer andthe contact layer.
 19. The method of claim 11 further comprising thestep of applying gel to the cutout area.
 20. The method of claim 11further comprising the step of attaching an adhesive washer around thecutout.
 21. The method of claim 11 further comprising the step ofcutting spiral cuts, the spiral cuts adaptable to surround the cutout.22. A wireless integrated patch produced according to the method ofclaim
 11. 23. The method of claim 11 further comprising more than onecutout and more than one contact.